(58 days)
Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.
Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. The software is post processing and does not control the scanning features of the system.
I am sorry, but the provided text does not contain a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for the Scenium device by Mirada Solutions Ltd., seeking clearance from the FDA. It mainly discusses:
- General company and contact information.
- Device description and its intended use (aid in assessment and quantification of pathologies from PET scans, particularly human brain scans using FDG-PET).
- Technological characteristics and safety/effectiveness concerns, stating compliance with quality system regulations and ISO 14971.
- A claim of substantial equivalence to predicate devices (NeuroQTM and GE Discovery ST).
- The FDA's letter of substantial equivalence determination, allowing the device to be marketed.
- The Indications for Use form.
While it mentions that "All requirements of the Emission Computed tomography system Standard, as outlined in 21 CFR 820.1200 have been met," and the software is in compliance with ISO 14971, it does not provide a table of acceptance criteria nor a detailed study that reports device performance against such criteria. The document focuses on regulatory clearance via substantial equivalence, not a performance study per se.
Therefore, I cannot provide the requested table and study details based on the information given.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.